Ryzodeg 70/30 FlexTouch

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Insulin aspart 30 U/mL; Insulin degludec 70 U/mL

Disponibil de la:

Novo Nordisk Pharmaceuticals Ltd

Dozare:

100 U/mL

Forma farmaceutică:

Solution for injection

Compoziție:

Active: Insulin aspart 30 U/mL Insulin degludec 70 U/mL Excipient: Glycerol Hydrochloric acid Metacresol Phenol Sodium chloride Sodium hydroxide Water for injection Zinc as acetate

Tip de prescriptie medicala:

Prescription

Indicații terapeutice:

For use in diabetes mellitus in patients aged 6 years and older

Rezumat produs:

Package - Contents - Shelf Life: Cartridge, glass, Type I, fitted into FlexTouch pen - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 30°C protect from light

Data de autorizare:

2021-12-03

Caracteristicilor produsului

Ryzodeg 70/30 Data Sheet
VV-LAB-107027
Page 1 of 22
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
RYZODEG
®
70/30 FlexTouch
®
solution for injection
RYZODEG
®
70/30 Penfill
®
solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RYZODEG 70/30 is a soluble insulin product consisting of insulin
degludec (ultra-long acting
basal insulin) and insulin aspart (rapid acting mealtime insulin)
administered in one injection.
1 mL of the solution contains 100 U insulin degludec/insulin aspart
(70% soluble insulin
degludec and 30% soluble insulin aspart) equivalent to 2.56 mg
salt-free anhydrous insulin
degludec and 1.05 mg salt-free anhydrous insulin aspart. One
pre-filled pen or cartridge
contains 3 mL, equivalent to 300 U of insulin degludec/insulin aspart.
Insulin
degludec
and
insulin
apart
are
produced
by
recombinant
DNA
technology
in
_Saccharomyces cerevisiae_.
Each mL of solution contains phenol 1.5 mg and metacresol 1.72 mg as
preservatives.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
RYZODEG 70/30 is a solution for injection.
RYZODEG 70/30 is a ready-to-use, clear, colourless, neutral solution
in pre-filled pen or
cartridge. RYZODEG 70/30 has a pH of approximately 7.4.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC
I
NDICATIONS
For use in diabetes mellitus in patients aged 6 years and older.
4.2.
D
OSE AND
M
ETHOD OF
A
DMINISTRATION
DOSAGE
RYZODEG 70/30 is a soluble insulin product consisting of the
ultra-long acting basal insulin
degludec and the rapid acting prandial insulin aspart in a ratio of
70:30.
RYZODEG 70/30 can be administered once- or twice-daily with the main
meal(s). However,
if advised by a healthcare professional, when needed, the patient can
change the time of
administration as long as RYZODEG 70/30 is dosed with the main meal
when taken once daily.
The potency of insulin analogues, including RYZODEG 70/30 is expressed
in units (U). 1 unit
(U) of RYZODEG 70/30 corresponds to 1 international unit (IU) of human
insulin and one unit
of most other ins